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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in chemico
Type of information:
experimental study
Adequacy of study:
key study
Study period:
59 days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
GLP compliance:
yes
Type of study:
direct peptide reactivity assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
EC Number:
921-112-4
Molecular formula:
C53H91N7O11
IUPAC Name:
N-(3β-hydroxyolean-12-en-28-oyl)-L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine
Test material form:
solid: particulate/powder

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Direct Peptide Reactivity Assay
Value:
32.04
Vehicle controls validity:
not valid
Negative controls validity:
not valid
Positive controls validity:
not valid
Remarks on result:
other: The reactivity class of test sustance was classified to " Moderate Reactivity" . The skin sensitivity was predicted as Positive

Applicant's summary and conclusion

Interpretation of results:
other: Reactivity of the sustance was classifiedd as "Moderate Reactivity" or predicts as "Positive".
Conclusions:
The Skin sensitisation evaluation by "In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA)" for N-(3β-hydroxyolean- 12-en-28-oyl)- L-lysyl-L-threonyl-L-threonyl-L-lysyl-L-Serine confirms it is classified as "Moderate Reactivity" or predicts as "Positive". The study is performed in compliance with guidelines OECD TG 442C.